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Father Inclusive Prenatal Care for Pregnancy (FIPC Trial)
N/A
Recruiting
Led By Wrenetha A Julion, PhD, MPH, RN
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 2 - six months post birth
Awards & highlights
FIPC Trial Summary
This trial project helps young families prepare for parenthood by expanding prenatal care to include fathers, and offering parent & co-parenting education, employment & educational support.
Who is the study for?
This trial is for first-time pregnant women and their partners who are willing to participate together in an interview. It's not open to those who don't speak English or Spanish, or have cognitive disabilities that affect understanding of the consent process.Check my eligibility
What is being tested?
The study tests a Father Inclusive Prenatal Care model aimed at preparing young men for parenting by enhancing relationship skills within routine prenatal care. This includes parent education, co-parenting programs, and support with education and employment.See study design
What are the potential side effects?
Since this trial involves educational and counseling interventions rather than medical treatments, traditional physical side effects are not applicable. Participants may experience emotional discomfort discussing personal topics.
FIPC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Infant Toddler Social & Emotional Assessment (BITSEA)
Change in Coparenting Relationship Questionnaire
Change in Julion Index of Paternal Involvement
+5 moreSecondary outcome measures
Change in Parent Health Questionnaire (PHQ9)
Change in Trait Emotional Intelligence Questionnaire
Maternal Health Outcome Assessment
Other outcome measures
Change in Administration for Children & Families Survey
Change in Participant Additional Demographics (e.g. Clinic-based Social Determinants of Health screening)
Change in Screen for Post-traumatic Stress Symptoms Questionnaire
+3 moreFIPC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Father Inclusive Prenatal CareExperimental Treatment1 Intervention
Co parenting, parenting education, employment and educational readiness training and support.
Group II: Standard CareActive Control1 Intervention
Participants will receive usual prenatal care services and information about community resources.
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Who is running the clinical trial?
Skills for Chicagoland's Future-ChicagoUNKNOWN
Parent Child Center (PCC) Community Wellness CenterUNKNOWN
Children's Bureau - Administration for Children and FamiliesOTHER
22 Previous Clinical Trials
39,629 Total Patients Enrolled
1 Trials studying Prenatal Care
11,811 Patients Enrolled for Prenatal Care
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My partner and I are willing to participate in the initial interview together.I am a pregnant woman who has never given birth.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care
- Group 2: Father Inclusive Prenatal Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies still available in this clinical research initiative?
"As per the information supplied on clinicaltrials.gov, this research has been open for recruitment since June 9th 2021 and was last modified in December 7th 2022."
Answered by AI
Does the population of this clinical trial encompass individuals aged 35 and above?
"To be qualified for this trial, participants must between the ages of 17 and 25. For those that are younger than 17 or older 65, there are 120 trials specifically designed to meet their needs."
Answered by AI
How many individuals are currently enrolled in this medical experiment?
"Affirmative. Per the information on clinicaltrials.gov, this research has been actively searching for participants since its original posting date of June 9th 2021 and was most recently updated on December 7th 2022. 800 individuals are needed to take part in this trial at a single site."
Answered by AI
To what demographic is admission to this research project open?
"This study requires 800 participants aged between 17 and 25 who are eligible for counseling. Additionally, the female subjects must be nulliparous and both genders need to agree to attend a baseline interview together."
Answered by AI
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